Analysis of Biopharmaceutical Lyophilizate Appearance and Structural State by X-Ray Microscopy (XRM) (CAT#: STEM-B-0424-CJ)

Introduction

The development of a lyophilized formulation and the corresponding freeze-drying process go hand in hand. An in-depth characterization of the freeze-dried powder during process development provides all relevant data require to optimize critical process parameters. Freeze-drying has advanced to the point where it is a common practice for biopharmaceuticals, including blood plasma and vaccines. Lyophilization is still a method of choice for preservation of the growing list of biopharmaceutical products.

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Principle Applications Procedure Materials Notes Related Products

Principle

X-ray microscopy is a complementary method to conventional visible light microscopy and electron imaging techniques like scanning and transmission electron microscopy (SEM/TEM). The critical advantage of XRM over optical microscopes is its 3D capability, which further allows for the visualization of bubbles, voids, and different materials. X-ray microscope emissions are narrowed into a tiny focal spot used to scan the sample.

Applications

Biopharmaceutica

Procedure

1. Sample preparation.
2. Place the sample on the instrument. By measuring the intensity distribution of X-rays that pass through the sample,
3. The 3D structure of the sample is visualized by rotating the X-ray transmission image obtained continuously by 180° on the computer (X-ray CT).

Materials

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more
• Equipment: X-Ray Microscopy (XRM)

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